HIC#: insert number
SAMPLE SHORT FORM WRITTEN CONSENT
200 FR.3 (2014-1)
FOR SUBJECTS WHO DO NOT SPEAK OR ARE UNABLE TO READ ENGLISH
THIS DOCUMENT MUST BE WRITTEN IN A LANGUAGE UNDERSTANDABLE TO THE SUBJECT
Specify both the Yale University academic research entity, and, if applicable, the non-academic partner, e.g.:
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL: SAINT RAPHAEL CAMPUS
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL: SMILOW CANCER CENTER
YALE UNIVERSITY SCHOOL OF MEDICINE—CONNECTICUT MENTAL HEALTH CENTER
YALE UNIVERSITY SCHOOL OF PUBLIC HEALTH
YALE UNIVERSITY SCHOOL OF NURSING—YALE NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE—THE APT FOUNDATION
YALE UNIVERSITY SCHOOL OF NURSING
Be sure to delete any entities that do not apply.
Study Title: [Insert title of the study.]
Principal Investigator: [Insert name.]
Consent to Participate in Research
You are being asked to participate in a research study.
Before you agree, the investigator must tell you about (i)the purposes, procedures, and duration of the research; (ii) any procedures which are experimental; (iii)any reasonably foreseeable risks, discomforts, and benefits of the research; (iv) any potentially beneficial alternative procedures or treatments; and (v) how confidentiality will be maintained.
Where applicable, the investigator must also tell you about (i) any available compensation or medical treatment if injury occurs; (ii)the possibility of unforeseeable risks; (iii) circumstances when the investigator may halt your participation; (iv) any added costs to you; (v) what happens if you decide to stop participating; (vi) when you will be told about new findings which may affect your willingness to participate; and (vii) how many people will be in the study.
If you agree to participate, you must be given a signed copy of this document and a written summary of the research.
You may contact ____name____ at ___phone number__ any time you have questions about the research or what to do if you are injured.
You may contact the Yale Human Research Protection Program (HRPP) at 203-785-4688 if you have questions about your rights as a research subject.
Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop.
Signing this document means that the research study, including the above information, has been described to you orally, and that you voluntarily agree to participate.
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Signature of Participant/LAR Date
______
Signature of Witness Date
(This should not be the person obtaining consent)
Witness/Interpreter
By signing this form you are indicating that:
· The information in the Summary Document (this is the short form) as well as any additional information conveyed by the research person obtaining consent was presented to the subject in a language preferred by and understandable to the subject
· The subject’s questions were interpreted and the responses of the person obtaining consent were presented in a language preferred by and understandable to the subject.
· At the conclusion of the consent conference the subject was asked in a language preferred by and understandable to the subject if s/he understood the information, and responded affirmatively.
______
Signature of Witness/Interpreter Date
NOTE: If an individual fluent in both languages signs as witness (e.g., a family member), the interpreter does not need to sign this form. If the study requires a witness and the Interpreter is the witness, she/he must also sign the consent summary (this is generally the IRB approved long consent form).